BEUDAMED
    FDA Recall Terminated

    PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0

    Recall: Z-2075-2021 · Initiated August 6, 2020

    Recall

    Recall Number
    Z-2075-2021
    Event Number
    88084
    Firm
    C-RAD POSITIONING AB Bredgrand 18 Uppsala Sweden
    FEI Number
    3006621300
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    August 6, 2020
    Terminated
    April 15, 2022

    Description

    PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0

    Reason

    PC Application Software c4D not changing Site upon synchronization during the Setup workflow step

    Action

    On August 11, 2020, an e-mail letter containing PA-003-200806-001-01, c4D not changing Site upon synchronization during the Setup workflow step (attached) has been sent personally to our contact persons at the affected sites. In a second step C-RAD upgraded the software at all affected sites to bring back the system to the originally intended state..

    Distribution

    US Nationwide distribution in the states of IL, KY, MO and WA.

    Quantity

    7